Prospective Randomized On-X Versus SJM Evaluation Trial
PROSE
Thromboembolic Related Complications in a Randomized Trial of Previous and Current Generation Mechanical Valve Prostheses
1 other identifier
interventional
857
9 countries
28
Brief Summary
The study hypothesizes that rate of thromboembolic complications of the On-X prosthesis is reduced as compared to the SJM prosthesis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2003
Longer than P75 for not_applicable
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2003
CompletedFirst Submitted
Initial submission to the registry
February 16, 2008
CompletedFirst Posted
Study publicly available on registry
March 20, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedMay 25, 2021
May 1, 2021
17.8 years
February 16, 2008
May 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Thromboembolisms
Frequency of occurrence for thromboembolic events, either major or reversible, as a function of valve type.
5 years
Study Arms (2)
ONX
ACTIVE COMPARATOROn-X heart Valve Replacement
SJM
ACTIVE COMPARATORSJM heart valve replacement
Interventions
On-X Heart valve replacement
SJM Heart valve replacement
Eligibility Criteria
You may qualify if:
- The patient requires an isolated mitral or isolated aortic valve replacement. (Patients undergoing coronary artery bypass and / or concomitant repair of mitral or tricuspid valves are eligible.)
- The patient is a candidate for receipt of a mechanical heart valve.
- The patient (or legal guardian) has signed a study-specific informed consent form agreeing to the randomization, data collection and follow-up requirements.
- The patient can be having a re-operative procedure, so long as the previous prosthetic valve is explanted and the patient does not become a double valve implantation patient.
You may not qualify if:
- The patient is not a candidate to receive a mechanical heart valve.
- The patient already has a prosthetic valve other than the valve(s) being replaced at this time.
- The patient requires a tricuspid valve replacement.
- The patient is enrolled in another investigative study or trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Southern California Permanente Medical Group
Los Angeles, California, 91101, United States
Kaiser Foundation Hospital
Honolulu, Hawaii, 96817, United States
Washington University - St Louis
St Louis, Missouri, 63110, United States
Christian Hospital Northeast
St Louis, Missouri, 63136, United States
Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
Royal Prince Alfred Hospital
Sydney, New South Wales, 2000, Australia
St. Paul's Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
Victoria Heart Institute
Victoria, British Columbia, V8R 4R2, Canada
Horizon New Brunswick Heart Centre
Saint John, New Brunswick, E2L 4L2, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Universitats-Herzzentrum Bad Krozingen
Freiburg im Breisgau, 79106, Germany
Universitats-Herzzentrum Freiburg - Medical Center
Freiburg im Breisgau, 79106, Germany
Universitats Klinik Jena
Jena, 7743, Germany
Universitat Klinik Tübingen
Tübingen, 72074, Germany
Sri Bachubahi Dayabhai Mehta Mahavir Heart Institute
Surat, Gujarat, 395 001, India
Shri Jaya Deva Institute of Cardiovascular Sciences
Bangalore, Karnataka, 560 069, India
Hero Dayanand Medical College and Hospitals
Ludhiana, Punjab, 141 001, India
Apollo Hospital Chennai
Chennai, Tamil Nadu, 600 006, India
Frontier Lifeline Hospital
Chennai, Tamil Nadu, 600 101, India
Apollo Multispecialty Hospitals
Madurai, Tamil Nadu, 625 020, India
Banaras Hindu University
Varanasi, Uttar Pradesh, 221 005, India
Erasmus Medical Center
Rotterdam, 3000 CA, Netherlands
University of Bergen
Bergen, N-5021, Norway
Groote Schuur Hospital
Cape Town, 7935, South Africa
Sahlgrenska University Hospital
Gothenburg, SE41345, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Jamieson, MD
Vancouver Coastal Health Research Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2008
First Posted
March 20, 2008
Study Start
July 1, 2003
Primary Completion
May 1, 2021
Study Completion
May 1, 2021
Last Updated
May 25, 2021
Record last verified: 2021-05